Product code HRS— Orthopedic
Treace Medical Concepts (TMC) Plating System
- Classification name
- Plate, Fixation, Bone
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Total cleared
- 1,322
- First cleared
- Most recent
Market context for product code HRS
FDA has cleared devices under product code HRS between 1976 and 2026, filed by 352 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code HRS
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HRS
1–100 of 1,322- K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more
- K262537 — Versalock Sterile Plating System
- K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
- K261511 — Xpert Ankle
- K261406 — Versalock Proximal Tibial Plating System
- K262032 — TriMed Non-Spanning Wrist Fusion Plates (4 models)
- K261191 — Alians Elbow S
- K261054 — RibPlate System
- K261351 — SALGINA 2.5mm Distal Radius System
- K260958 — I.T.S. Clavicle Plates with Angular Stability +11 more
- K261207 — Exalta Proximal Tibia Plating System
- K260761 — APTUS Clavicle System 2.8
- K261002 — Pectus Blu System
- K261038 — Xpert PFP
- K261145 — Avanti Distal Elbow ORIF System
- K260323 — OrthoPediatrics® Locking Cannulated Blade Plate System
- K260054 — I.T.S. PRS Phoenix II
- K260228 — POYA 3.5mm Medial Proximal Tibia System
- K260411 — PC Fix System
- K260090 — SMART Osteotomy System
- K253718 — enHAnce PEEK Bunion System
- K260274 — Airlock® Ankle Plating System
- K260291 — Vortex5 Tailor's Bunion Correction System
- K254253 — LOQTEQ® VA Proximal Humerus Plate 3.5
- K254288 — Clavicle Fixation System
- K260448 — CastleLoc Pectus Bar System
- K254053 — APS Spear Locking Plate
- K260390 — Super Upper Limbs Versalock Plating System
- K253916 — APTUS Shoulder Proximal Humerus System, PentaLock 3.5
- K253906 — Xpert Hand
- K260069 — DePuy Synthes VOLT Proximal Tibia 3.5 Plating System
- K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
- K254054 — VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System
- K254249 — HKT Anatomical Locking Trauma System
- K252166 — RIB LINK Fixation System
- K253660 — KLS Martin Pure Pectus System
- K254162 — KLS Martin Ixos System
- K251732 — Wrist Fracture System
- K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System
- K254002 — TriMed Volar Bearing Plates (6 models)
- K252807 — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
- K253178 — TRILEAP Plating System
- K251050 — Pectus Versa System
- K252191 — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
- K250988 — KLS Martin Pure Pectus System
- K252897 — APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw) +5 more
- K252997 — HyperFlex® Bunion Correction System
- K252661 — SternaFuse Ti Fixation System
- K253423 — ToeJack MIS Bunion System
- K250865 — KLS Martin IPS Forearm System
- K252949 — Geminus Volar Distal Radius Plating System
- K252959 — WRISTAR MultiAx Distal Radius Kit
- K253300 — Fine Osteotomy
- K252600 — Pediatric Plating Platform I Small-Mini
- K251892 — MAXXOS P.A.C.E. Foot & Ankle Plating System
- K250923 — Fine Osteotomy
- K251135 — Treace Medical Concepts (TMC) Implant Fixation System
- K252356 — The Acumed Wrist Fixation System - 2.4mm Screws
- K252061 — Distal Xtremities System
- K251161 — ANTHEM® Fracture System
- K251913 — OsteoCentric® UnifiMI® TCS Plating System
- K250620 — KLS Martin Ixos System
- K251361 — Tyber Medical Distal Radius Plating System
- K251620 — A.L.P.S. Proximal Humerus Plating System
- K250952 — Baby Gorilla®/Gorilla® Plating System
- K251132 — The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
- K251945 — TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
- K242988 — Genostis Osteosynthesis System
- K243275 — Equinoxe® Scapula Fracture System
- K250929 — TriMed Ulnar Osteotomy System (4 models)
- K251296 — The Acumed Wrist Fixation System
- K250933 — LORRAINE 2.5/3.5mm Distal Humerus System
- K243368 — Montblanc Plate System
- K242751 — ARIX Pectus Bar System
- K243469 — SIGNEX
- K250935 — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
- K243963 — Pediatric Plating Platform Hip
- K250892 — CastleLoc Pectus Bar System
- K242973 — CanMINI Hand and Foot System
- K250155 — Xpert Knee
- K250948 — TriMed Fusion Cup System
- K243995 — Arthrex Humeral Plating System and Cerclage Button
- K242486 — Tyber Medical Anatomical Plating System
- K243987 — TriMed Elbow and Forearm System
- K243999 — TriMed Ankle Fixation System
- K250494 — The OsteoCentric Bone Plate and Screw System
- K250498 — BPS Wrist Fracture System
- K243610 — APTUS Hand System; APTUS Elbow Dorsal Olecranon
- K243357 — CastleLoc Pectus Bar System
- K241666 — EVOS Pelvic and Acetabular System
- K243761 — A.L.P.S. Small Fragment Plating System
- K240958 — Locking Plates and Screws Systems
- K241599 — Signature Osteosynthesis Plate System
- K250055 — BPS - Bone Fragment Fixation Plates, Screws and Washers
- K243740 — Versalock Upper Limb Plating System
- K243569 — TriMed Wrist Fixation System (10 models)
- K242939 — ARTFX Trauma Bone Plate and Screw System
- K243308 — Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
- K243491 — SternalPlate Expansion
- K241128 — TDM Plate and Screw System
Data sourced from openFDA. This site is unofficial and independent of the FDA.